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Veleka Peeples-Dyer

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Veleka Peeples-Dyer is Chair, North America FDA Practice Group for Baker McKenzie. Veleka brings more than 20 years of strategic and practical business and legal counsel to a wide span of biopharmaceutical companies, advising on FDA regulatory and compliance matters, including over 15 years of senior in-house counsel experience in leading biopharmaceutical companies.

The Health Pod, Baker McKenzie’s industry podcast series, highlights sector-specific issues and trends that affect healthcare and life sciences companies. Episode 5: Japan Pharmaceuticals Market – Distinguishing Features and Industry Practice Japan accounts for approximately 7% of the global pharmaceuticals market and is the third-largest market in the world following…

The Health Pod, Baker McKenzie’s industry podcast series, highlights sector-specific issues and trends that affect healthcare and life sciences companies. Episode 5: Japan Pharmaceuticals Market – Distinguishing Features and Industry Practice Japan accounts for approximately 7% of the global pharmaceuticals market and is the third-largest market in the world following…

In brief On 22 October 2020, the FDA approved the anti-viral drug Veklury (remdesivir) for hospitalized COVID-19 patients, making it the first drug to receive approval for the treatment of COVID-19. Before approving this drug, the FDA issued an Emergency Use Authorization for the use of Veklury in COVID-19 treatment. We will…

Whether you are managing the immediate crisis, stabilizing operations or looking beyond to what a world after COVID-19 will look like, this series features key practical insights intended to strengthen your organization’s capacity to respond, recover and thrive. Subscribe: Apple Podcasts | Spotify | Google Podcasts Episode 11: How Green is Green? The Growth of…

FDA Food Safety Modernization Act Proposed Rule to Advance Traceability of Foods Key Takeaways On September 23, 2020, the Food and Drug Administration (FDA, the Agency) released its proposal to establish additional recordkeeping requirements for those that manufacture, process, pack, or hold foods on the Food Traceability List by collecting…

With the healthcare and life sciences sector at the heart of the pandemic, we are seeing some new issues arising in the already complex world of life sciences collaborations, for both coronavirus-related and other products and therapies. The Life Sciences Collaborations: Key Considerations in the COVID-19 Era document is a…

Key Takeaway It is vital for manufacturers of market-critical drug products to survey their supply chain and current available product supply to ensure compliance with reporting requirements. Further, while FDA inspections of manufacturing facilities in China are currently not taking place, the FDA has increased import sampling and screening in…